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Weight loss program aims to cut cancer risk in BRCA and lynch syndrome carriers

NCT ID NCT04125914

Disease control Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a weight management and health behavior program for people with BRCA or Lynch syndrome mutations, who have a higher risk of certain cancers. Participants receive diet tracking, exercise guidance, phone coaching, and online support to help them lose weight and adopt healthier habits. The goal is to see if these lifestyle changes can lower cancer risk in this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
behavioral intervention (diet, exercise, coaching, text messages, Facebook group)
What this could lead to
If successful, this program could help people with hereditary cancer mutations lower their cancer risk through lifestyle changes.
What could go wrong
This is an early-stage behavioral study, not a drug trial. Results depend on participants sticking with the program, and it may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 384 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2017

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * HEALTH4Families only: Positive for either HBOC or LS predisposing mutations OR a family member of a mutation carrier (family members do not need to be biological relatives). * HEALTH4Families only: Index participant ONLY: Must have at least one family member who is eligible and consents to participation. * Have at least one of the following risk factors: * Body mass index (BMI) of 25 or higher * \< 5 servings of vegetables and fruits per day * \< 150 minutes per week of moderate intensity activity * 75 minutes per week of vigorous intensity activity * Able to read and write English. * Have a cellular telephone and are able and willing to send and receive text messages. * Access to internet via desktop or mobile device. * Capable of participating in moderate-vigorous unsupervised exercise. * HEALTH4CPC only: Patient in MD Anderson's Cancer Prevention Center coming in to the clinic for one of the following appointment types: consult and new patient screening appointments * HEALTH4CPC only: Female. * HEALTH4CPC only: Lives in the Houston area or surrounding counties (within 150 miles of MD Anderson's main campus). * HEALTH4CPC only: Has a smartphone. Exclusion Criteria: * Unable to walk without crutches, walker, cane, or other assistive device. * Women who are pregnant or nursing (by self-report). * Currently receiving radiation therapy or cytotoxic chemotherapy. * Within 3 months of major surgery. * Does not live in the United States. * HEALTH4CPC only: Persons diagnosed with any invasive cancer excluding non-melanoma skin cancer. * HEALTH4CPC only: Patient at high risk for cancer. * HEALTH4CPC only: Participated in the HEALTH 4 MD Anderson pilot study (protocol 2014-0230).

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Conditions

The condition(s) this trial relates to.

Colorectal Neoplasms, Hereditary Nonpolyposis familial ovarian carcinoma hereditary breast carcinoma hereditary breast ovarian cancer syndrome Lynch syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hereditary breast carcinoma Hereditary ovarian carcinoma Lynch syndrome

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

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